Pub Date : 2020-01-01DOI: 10.35248/2153-2435.20.11.625
S. Gharai
Pharmacological mediation is accessible for almost all wellbeing related conditions; be that as it may, serious and on occasion irreversible harm to different sound tissues is a significant medical issue worldwide and remains the absolute most significant difficulty of treatment as it might restrain further treatment or even undermine life. To address this significant issue, enormous exertion has been attempted in the course of recent decades to create novel medication conveyance frameworks that calm these hazardous symptoms and at last improve long haul results. The guarantee of medication conveyance frameworks is higher explicitness and strength with diminished reactions; a few cutting edge conveyance advancements are clinically executed, these frameworks have one of a kind points of interest and confinements [1].
{"title":"Present Benefit in Drug Administration","authors":"S. Gharai","doi":"10.35248/2153-2435.20.11.625","DOIUrl":"https://doi.org/10.35248/2153-2435.20.11.625","url":null,"abstract":"Pharmacological mediation is accessible for almost all wellbeing related conditions; be that as it may, serious and on occasion irreversible harm to different sound tissues is a significant medical issue worldwide and remains the absolute most significant difficulty of treatment as it might restrain further treatment or even undermine life. To address this significant issue, enormous exertion has been attempted in the course of recent decades to create novel medication conveyance frameworks that calm these hazardous symptoms and at last improve long haul results. The guarantee of medication conveyance frameworks is higher explicitness and strength with diminished reactions; a few cutting edge conveyance advancements are clinically executed, these frameworks have one of a kind points of interest and confinements [1].","PeriodicalId":19833,"journal":{"name":"Pharmaceutica Analytica Acta","volume":"103 1","pages":"1-1"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88949403","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-01-01DOI: 10.35248/2153-2435.20.11.627
Swedha Verma
{"title":"An Archive of 11 years in Pharmaceutical Science","authors":"Swedha Verma","doi":"10.35248/2153-2435.20.11.627","DOIUrl":"https://doi.org/10.35248/2153-2435.20.11.627","url":null,"abstract":"","PeriodicalId":19833,"journal":{"name":"Pharmaceutica Analytica Acta","volume":"91 1","pages":"1-1"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74821354","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-01-01DOI: 10.35248/2153-2435.20.11.618
ip S. Chaudhari, Swapnil D. Phalak
YOSPRALA is newly designed tablet which effective in cardiovascular as well as gastrointestinal protection due to its immediate release of Omeprazole (40 mg) and delayed release of Aspirin (81 mg) or (325 mg) dose strength. Yosprala was approved by USFDA in Sept 2016 for cardiovascular and cerebrovascular diseases. Aspirin is an antiplatelet agent & Omeprazole is proton pump inhibitor therefore it is made to develop a new analytical method for Simultaneous estimation of Aspirin and Omeprazole using Mehtanol as a solvent on the basis of solubility. The maximum Absorption (λ max) of Aspirin and Omeprazole was found at 276 and 301 respectively. Linearity range for aspirin was given at 10-50 μg/ml with %RSD value 0.997 and Omeprazole was 2-10 μg/ml with %RSD value 0.997. The method was validated for precision and % RSD was found less than 2.0 for both aspirin and omeprazole. The proposed method was statistically validated for standard deviation, relative standard deviation, coefficient of variance and the results were within the range. Hence the above method was simple, cheap, cost effective, economical, and robust.
{"title":"Development and validation of UV Spectrophotometric method for simultaneous equation of Aspirin and Omeprazole in tablet dosage form","authors":"ip S. Chaudhari, Swapnil D. Phalak","doi":"10.35248/2153-2435.20.11.618","DOIUrl":"https://doi.org/10.35248/2153-2435.20.11.618","url":null,"abstract":"YOSPRALA is newly designed tablet which effective in cardiovascular as well as gastrointestinal protection due to its immediate release of Omeprazole (40 mg) and delayed release of Aspirin (81 mg) or (325 mg) dose strength. Yosprala was approved by USFDA in Sept 2016 for cardiovascular and cerebrovascular diseases. Aspirin is an antiplatelet agent & Omeprazole is proton pump inhibitor therefore it is made to develop a new analytical method for Simultaneous estimation of Aspirin and Omeprazole using Mehtanol as a solvent on the basis of solubility. The maximum Absorption (λ max) of Aspirin and Omeprazole was found at 276 and 301 respectively. Linearity range for aspirin was given at 10-50 μg/ml with %RSD value 0.997 and Omeprazole was 2-10 μg/ml with %RSD value 0.997. The method was validated for precision and % RSD was found less than 2.0 for both aspirin and omeprazole. The proposed method was statistically validated for standard deviation, relative standard deviation, coefficient of variance and the results were within the range. Hence the above method was simple, cheap, cost effective, economical, and robust.","PeriodicalId":19833,"journal":{"name":"Pharmaceutica Analytica Acta","volume":"8 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73921198","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-01-01DOI: 10.35248/2153-2435.20.11.620
S. Murad, Manal Raouf Mahar, J. Murad, S. Saif, A. G. Mastoi, Altaf Hussain, M. I. Mastoi
CHD tends to develop when cholesterol builds up on the artery walls, creating plaques. These plaques cause the arteries to narrow, reducing blood flow to the heart. Coronary Artery Disease is caused by plaque buildup in the walls of the arteries that supply blood to the heart (called coronary arteries) and other parts of the body. Plaque is made up of deposits of cholesterol and other substances in the artery. Plaque buildup causes the inside of the arteries to narrow over time, which could partially or totally block the blood flow. Coronary artery disease (CAD), when get worst, it is known as coronary artery syndrome (CAS). We compared Rosuvastatin 10 mg with Indian dates (Jujubes) as hypolipidemic agents. Their baseline parameters like LDL-cholesterol, HDL-cholesterol, systolic/diastolic blood pressure was determined in the hospital laboratory. It was observed that Rosuvastatin significantly decreased systolic/diastolic blood pressure, LDL-cholesterol, and increased HDL-cholesterol in 27 hyperlipidemic/hypertensive patients. Indian dates used in 30 hyperlipidemic patients significantly decreased systolic blood pressure, and LDL-cholesterol, but insignificant changes were seen in diastolic blood pressure, and HDL-cholesterol. We concluded from the research work that Rosuvastatin is potent hypolipidemic and hypotensive medicine as compared to indian dates.
{"title":"Ancient Sources of Therapeutics","authors":"S. Murad, Manal Raouf Mahar, J. Murad, S. Saif, A. G. Mastoi, Altaf Hussain, M. I. Mastoi","doi":"10.35248/2153-2435.20.11.620","DOIUrl":"https://doi.org/10.35248/2153-2435.20.11.620","url":null,"abstract":"CHD tends to develop when cholesterol builds up on the artery walls, creating plaques. These plaques cause the arteries to narrow, reducing blood flow to the heart. Coronary Artery Disease is caused by plaque buildup in the walls of the arteries that supply blood to the heart (called coronary arteries) and other parts of the body. Plaque is made up of deposits of cholesterol and other substances in the artery. Plaque buildup causes the inside of the arteries to narrow over time, which could partially or totally block the blood flow. Coronary artery disease (CAD), when get worst, it is known as coronary artery syndrome (CAS). We compared Rosuvastatin 10 mg with Indian dates (Jujubes) as hypolipidemic agents. Their baseline parameters like LDL-cholesterol, HDL-cholesterol, systolic/diastolic blood pressure was determined in the hospital laboratory. It was observed that Rosuvastatin significantly decreased systolic/diastolic blood pressure, LDL-cholesterol, and increased HDL-cholesterol in 27 hyperlipidemic/hypertensive patients. Indian dates used in 30 hyperlipidemic patients significantly decreased systolic blood pressure, and LDL-cholesterol, but insignificant changes were seen in diastolic blood pressure, and HDL-cholesterol. We concluded from the research work that Rosuvastatin is potent hypolipidemic and hypotensive medicine as compared to indian dates.","PeriodicalId":19833,"journal":{"name":"Pharmaceutica Analytica Acta","volume":"34 1","pages":"1-3"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77915329","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-01-01DOI: 10.35248/2153-2435.20.11.621
N. Sagar, A. Rahul, N. Rajani
The main objective of this work is to explore co-crystallization approach for increasing solubility of an antiretroviral drug, Ritonavir (RTN). In this study, different co-formers with different functional groups like carboxylic acid andacid amidewere tried in ratio of 1:1, 1:2 and 1:3 (RTN:Co-former) using neat grinding method. Co-formers used were citric acid (CIT) and adipic acid (ADP). The co-crystals formed were characterized by melting point determination, Fourier-transform infrared (FTIR), differential scanning calorimetry (DSC), X-ray diffraction (XRD) and solubility studies. Co-crystals of drug with CIT and ADP showed the improved dissolution profile when compared to the pure RTN. Melting point, DSC, FTIR spectra of co-crystals were different than pure drug and co-formers indicating their interaction. XRD patterns of co-crystals were not completely amorphous but less intense compared to drug alone.
{"title":"Solubility Enhancement of Ritonavir: Co-Crystallization","authors":"N. Sagar, A. Rahul, N. Rajani","doi":"10.35248/2153-2435.20.11.621","DOIUrl":"https://doi.org/10.35248/2153-2435.20.11.621","url":null,"abstract":"The main objective of this work is to explore co-crystallization approach for increasing solubility of an antiretroviral drug, Ritonavir (RTN). In this study, different co-formers with different functional groups like carboxylic acid andacid amidewere tried in ratio of 1:1, 1:2 and 1:3 (RTN:Co-former) using neat grinding method. Co-formers used were citric acid (CIT) and adipic acid (ADP). The co-crystals formed were characterized by melting point determination, Fourier-transform infrared (FTIR), differential scanning calorimetry (DSC), X-ray diffraction (XRD) and solubility studies. Co-crystals of drug with CIT and ADP showed the improved dissolution profile when compared to the pure RTN. Melting point, DSC, FTIR spectra of co-crystals were different than pure drug and co-formers indicating their interaction. XRD patterns of co-crystals were not completely amorphous but less intense compared to drug alone.","PeriodicalId":19833,"journal":{"name":"Pharmaceutica Analytica Acta","volume":"29 1","pages":"1-7"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73316769","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-01-01DOI: 10.35248/2153-2435.20.11.622
Kishor A. Bellad, B. Nanjwade, Arindam Sarkar, T. Srichana, Roopali M. Shetake
In the present study, curcumin an anti-inflammatory agent, was first complexed with the soluplus by hot melt extrusion machine to enhance the solubility of curcumin and was formulated into floating tablets by direct compression method. Tablets were formulated using various grades of Hydroxypropyl methylcellulose (HPMC) polymers and sodium bicarbonate as gas generating agent. Preformulation and micromeritic studies were performed. The floating tablets were evaluated for their physico-chemical properties, in-vitro release, in-vivo floating property, pharmacokinetic and stability studies. Formulations were found uniform with respect to thickness (5.11 to 5.27 mm) and hardness (4.4 to 4.8 kg/cm2). The friability (0.27 to 0.53 %), weight variation (1.28-1.89%) and Drug content (97.84 to 99.46 %). The order of swelling index of HPMC was found to be K100M > K15M > K4M. Sodium bicarbonate at the concentration of 16% w/w was found to be sufficient in attaining the buoyancy. The buoyancy lag time was found to be less than 1 minute for all the prepared tablets. The total floating time for different formulations was in the range of 12-24 hours. The optimized formulation F4, and F6 showed 98.85 and 98.10 % drug release at the end of 20 and 24 hrs respectively. The in-vivo floating study was carried out by X-ray imaging showed floating of the tablet in the stomach. The pharmacokinetic study showed, Cmax-260 ng/ml, Tmax-12 hrs, AUC -738.33 ng/hr/ml Kel as 0.061 and t1/2 was found to be 11.36 hrs. FT-IR, XRD and DSC studies revealed no chemical interaction between drug and polymers. During the stability period selected tablets were found to be stable with respect to floating behaviour and drug release characteristics.
{"title":"Development and Evaluation of Curcumin Floating Tablets","authors":"Kishor A. Bellad, B. Nanjwade, Arindam Sarkar, T. Srichana, Roopali M. Shetake","doi":"10.35248/2153-2435.20.11.622","DOIUrl":"https://doi.org/10.35248/2153-2435.20.11.622","url":null,"abstract":"In the present study, curcumin an anti-inflammatory agent, was first complexed with the soluplus by hot melt extrusion machine to enhance the solubility of curcumin and was formulated into floating tablets by direct compression method. Tablets were formulated using various grades of Hydroxypropyl methylcellulose (HPMC) polymers and sodium bicarbonate as gas generating agent. Preformulation and micromeritic studies were performed. The floating tablets were evaluated for their physico-chemical properties, in-vitro release, in-vivo floating property, pharmacokinetic and stability studies. Formulations were found uniform with respect to thickness (5.11 to 5.27 mm) and hardness (4.4 to 4.8 kg/cm2). The friability (0.27 to 0.53 %), weight variation (1.28-1.89%) and Drug content (97.84 to 99.46 %). The order of swelling index of HPMC was found to be K100M > K15M > K4M. Sodium bicarbonate at the concentration of 16% w/w was found to be sufficient in attaining the buoyancy. The buoyancy lag time was found to be less than 1 minute for all the prepared tablets. The total floating time for different formulations was in the range of 12-24 hours. The optimized formulation F4, and F6 showed 98.85 and 98.10 % drug release at the end of 20 and 24 hrs respectively. The in-vivo floating study was carried out by X-ray imaging showed floating of the tablet in the stomach. The pharmacokinetic study showed, Cmax-260 ng/ml, Tmax-12 hrs, AUC -738.33 ng/hr/ml Kel as 0.061 and t1/2 was found to be 11.36 hrs. FT-IR, XRD and DSC studies revealed no chemical interaction between drug and polymers. During the stability period selected tablets were found to be stable with respect to floating behaviour and drug release characteristics.","PeriodicalId":19833,"journal":{"name":"Pharmaceutica Analytica Acta","volume":"11 1","pages":"1-11"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75460407","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-01-01DOI: 10.35248/2153-2435.20.11.623
Deeptipiya Baniya, Kiran Bikram Bohara, Dharma Pd. Khanal, Saroj K Bashyal, P. Shahi
Objective: The plot of this study is to obtain a grasp regarding the effect of different fluids (Gastric medium, simulated gastric fluid without enzyme, ORS solution, rice water, lentil soup, watermelon juice, apple juice, mango juice, pomegranate juice, black and green tea) on dissolution of metronidazole tablet by alteration of different medium. Method: Our study had focused on the in vitro dissolution study of metronidazole in the presence of different fluids (Gastric medium, simulated gastric fluid without enzyme, ORS solution, rice water, lentil soup, watermelon juice, apple juice, mango juice, pomegranate juice, black and green tea) which has been commonly used in diarrheal condition to obtain quickest and profound dissolution for the metronidazole tablet. Different dissolution medium was prepared from 200 ml of fluids and 700 ml of 0.1 N HCl. pH was adjusted to pH 1.2. One commonly available marketed brand is used for the study. Dissolution study was performed as per mentioned in Indian pharmacopoeia. For the analysis of study, we used Graph Pad prism version 8 and Microsoft excel. ANOVA followed by Tukey's test was performed for the comparison of dissolution in different fluids Result: The mean dissolution of metronidazole tablet in Rice water, Lentil soup, Watermelon juice, Mango juice, Pomegranate juice, Black tea and Green tea are significantly different from the dissolution on 0.1 N HCl medium (p 0.05, 95% CI).The highest percentage drug release of Metronidazole was found in apple juice (102.78 ± 2.10). In lentil soup dissolution of Metronidazole doesn’t complies with the IP specification (78.69 ± 1.89). Conclusion: Metronidazole tablet plays a vital role in treatment of diarrhea but before it shows its therapeutic effect on body, it must have to dissolve first. So, dissolution is considered as an important parameter to determine the bioavailability of drug as well as its efficacy. Our study concludes that administration of apple juice can be beneficial on other hand lentil soup can decrease the therapeutic effect of metronidazole tablet.
目的:了解不同液体(胃培养基、无酶模拟胃液、ORS溶液、米水、扁豆汤、西瓜汁、苹果汁、芒果汁、石榴汁、红茶和绿茶)通过改变不同介质对甲硝唑片溶出度的影响。方法:对甲硝唑在不同腹泻常用液体(胃培养基、无酶模拟胃液、ORS溶液、米水、扁豆汤、西瓜汁、苹果汁、芒果汁、石榴汁、红茶和绿茶)存在下的体外溶出度进行研究，以获得甲硝唑片最快、最彻底的溶出度。用200 ml液体和700 ml 0.1 N HCl配制不同的溶解介质。pH调整至pH 1.2。研究中使用了一种常见的市场品牌。溶出度研究按照印度药典进行。为了分析研究，我们使用graphpad prism version 8和Microsoft excel。结果:甲硝唑片在米水、扁豆汤、西瓜汁、芒果汁、石榴汁、红茶和绿茶中的平均溶出度与在0.1 N HCl培养基中的溶出度有显著差异(p < 0.05, 95% CI)。甲硝唑在苹果汁中的释药率最高(102.78±2.10)。甲硝唑在扁豆汤中的溶出度不符合IP标准(78.69±1.89)。结论:甲硝唑片在治疗腹泻中起着至关重要的作用，但在对机体产生治疗效果之前，必须先溶解。因此，溶出度被认为是决定药物生物利用度和药效的重要参数。我们的研究表明，苹果汁对甲硝唑片的治疗有好处，而扁豆汤则会降低甲硝唑片的治疗效果。
{"title":"In Vitro Dissolution Study of Metronidazole Tablet in Different Fluids","authors":"Deeptipiya Baniya, Kiran Bikram Bohara, Dharma Pd. Khanal, Saroj K Bashyal, P. Shahi","doi":"10.35248/2153-2435.20.11.623","DOIUrl":"https://doi.org/10.35248/2153-2435.20.11.623","url":null,"abstract":"Objective: The plot of this study is to obtain a grasp regarding the effect of different fluids (Gastric medium, simulated gastric fluid without enzyme, ORS solution, rice water, lentil soup, watermelon juice, apple juice, mango juice, pomegranate juice, black and green tea) on dissolution of metronidazole tablet by alteration of different medium. Method: Our study had focused on the in vitro dissolution study of metronidazole in the presence of different fluids (Gastric medium, simulated gastric fluid without enzyme, ORS solution, rice water, lentil soup, watermelon juice, apple juice, mango juice, pomegranate juice, black and green tea) which has been commonly used in diarrheal condition to obtain quickest and profound dissolution for the metronidazole tablet. Different dissolution medium was prepared from 200 ml of fluids and 700 ml of 0.1 N HCl. pH was adjusted to pH 1.2. One commonly available marketed brand is used for the study. Dissolution study was performed as per mentioned in Indian pharmacopoeia. For the analysis of study, we used Graph Pad prism version 8 and Microsoft excel. ANOVA followed by Tukey's test was performed for the comparison of dissolution in different fluids Result: The mean dissolution of metronidazole tablet in Rice water, Lentil soup, Watermelon juice, Mango juice, Pomegranate juice, Black tea and Green tea are significantly different from the dissolution on 0.1 N HCl medium (p 0.05, 95% CI).The highest percentage drug release of Metronidazole was found in apple juice (102.78 ± 2.10). In lentil soup dissolution of Metronidazole doesn’t complies with the IP specification (78.69 ± 1.89). Conclusion: Metronidazole tablet plays a vital role in treatment of diarrhea but before it shows its therapeutic effect on body, it must have to dissolve first. So, dissolution is considered as an important parameter to determine the bioavailability of drug as well as its efficacy. Our study concludes that administration of apple juice can be beneficial on other hand lentil soup can decrease the therapeutic effect of metronidazole tablet.","PeriodicalId":19833,"journal":{"name":"Pharmaceutica Analytica Acta","volume":"36 1","pages":"1-5"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89049496","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-01-01DOI: 10.35248/2153-2435.19.10.611
Ravi Prasad Rao, P. Mogadati, S. Arutla, Mahibalan Senthi
In the recent past, delivery of therapeutic agents through the nasal route becoming a very attractive proposition, especially when rapid absorption and effects are required. The droplets size of a nasal spray dosage form is important for both efficacy and toxicity. In this study, an attempt was made to develop and validate a method to measure the droplets size distribution in Fluticasone nasal spray using Malvern spray tech coupled with automatic actuation station at various angles. Devices were actuated at the force of 6.0 kg, the velocity at 60 mm/s and rate of acceleration at 5000 mm/s2. Data was collected for 150 ms at a height of 6.0 cm from the tip of the device. The method was evaluated for their precision, robustness and impact of different actuation angle on the formation of droplets size. The study revealed that changing the actuation angle from 0° to 45° had no significant impact on droplets size distribution of brand-B, whereas, the Dv (90) of brand-A significantly affected. The repeatability of the method was assessed from the percent standard deviation of six replicate measurements and was found to be 3.2, 5.3, 9.1 and 11.1 for Dv (10), Dv (50), Dv (90) and less than 10 µm respectively. Similarly, the robustness of the method was evaluated by changing velocity and acceleration. When the velocity changed to 55 and 65 from 60 mm/s the percent difference in their Dv (10), Dv (50) and Dv (90) was found to be -4.2, -7.6 and -11.4 for 55 mm/s and 0.4, 0.2 and 0.5 for 65 mm/s. When the acceleration changed to 4500 and 5500 from 5000 mm/s2 the percent difference in their Dv (10), Dv (50) and Dv (90) was found to be -2.6, -1.7 and 0.1 for 4500 mm/s2 and -3.3, -1.7 and 0.5 for 5500 mm/s2. The results suggest that change in velocity and acceleration does not impact significantly on droplets size, thus ensures the robustness of the method. The method was applied to two commercially available nasal sprays labeled as Brand-A and Brand-B. The result has shown marginal differences in their Dv (10 and 50) but a significant difference observed in Dv (90) and Dv E10. The Dv (90) and Dv E10 of Brand-A and Brand-B was found to be 91.7; 0.8 and 66.9; 2.1µm respectively. The data presented here suggest that the developed method is precise and robust can distinguish the droplets size change in the products. Hence, this can be adopted in the pharmaceutical industries to check the characteristics of the spray products.
{"title":"Development and Validation of Robust Analytical Method to Determine Droplets Size Distribution of Nasal Spray Using Laser Diffraction Technique","authors":"Ravi Prasad Rao, P. Mogadati, S. Arutla, Mahibalan Senthi","doi":"10.35248/2153-2435.19.10.611","DOIUrl":"https://doi.org/10.35248/2153-2435.19.10.611","url":null,"abstract":"In the recent past, delivery of therapeutic agents through the nasal route becoming a very attractive proposition, especially when rapid absorption and effects are required. The droplets size of a nasal spray dosage form is important for both efficacy and toxicity. In this study, an attempt was made to develop and validate a method to measure the droplets size distribution in Fluticasone nasal spray using Malvern spray tech coupled with automatic actuation station at various angles. Devices were actuated at the force of 6.0 kg, the velocity at 60 mm/s and rate of acceleration at 5000 mm/s2. Data was collected for 150 ms at a height of 6.0 cm from the tip of the device. The method was evaluated for their precision, robustness and impact of different actuation angle on the formation of droplets size. The study revealed that changing the actuation angle from 0° to 45° had no significant impact on droplets size distribution of brand-B, whereas, the Dv (90) of brand-A significantly affected. The repeatability of the method was assessed from the percent standard deviation of six replicate measurements and was found to be 3.2, 5.3, 9.1 and 11.1 for Dv (10), Dv (50), Dv (90) and less than 10 µm respectively. Similarly, the robustness of the method was evaluated by changing velocity and acceleration. When the velocity changed to 55 and 65 from 60 mm/s the percent difference in their Dv (10), Dv (50) and Dv (90) was found to be -4.2, -7.6 and -11.4 for 55 mm/s and 0.4, 0.2 and 0.5 for 65 mm/s. When the acceleration changed to 4500 and 5500 from 5000 mm/s2 the percent difference in their Dv (10), Dv (50) and Dv (90) was found to be -2.6, -1.7 and 0.1 for 4500 mm/s2 and -3.3, -1.7 and 0.5 for 5500 mm/s2. The results suggest that change in velocity and acceleration does not impact significantly on droplets size, thus ensures the robustness of the method. The method was applied to two commercially available nasal sprays labeled as Brand-A and Brand-B. The result has shown marginal differences in their Dv (10 and 50) but a significant difference observed in Dv (90) and Dv E10. The Dv (90) and Dv E10 of Brand-A and Brand-B was found to be 91.7; 0.8 and 66.9; 2.1µm respectively. The data presented here suggest that the developed method is precise and robust can distinguish the droplets size change in the products. Hence, this can be adopted in the pharmaceutical industries to check the characteristics of the spray products.","PeriodicalId":19833,"journal":{"name":"Pharmaceutica Analytica Acta","volume":"33 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72908119","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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